Rifabutin Containing Triple Therapy and Rifabutin with Bismuth Containing Quadruple Therapy for Third‐Line Treatment of <i>Helicobacter pylori</i> Infection: Two Pilot Studies

Ciccaglione, Antonio Francesco; Tavani, R.; Grossi, Laurino; Cellini, Luigina; Manzoli, Lamberto; Marzio, L.

doi:10.1111/hel.12296

Cited by 32 publications

(35 citation statements)

References 53 publications

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“…This was a prospective single‐center, randomized, open‐label trial conducted as two pilot studies in adult patients with H pylori infection as described previously …”

Section: Methodsmentioning

confidence: 99%

Twice‐a‐day PPI, tetracycline, metronidazole quadruple therapy with Pylera® or Lactobacillus reuteri for treatment naïve or for retreatment of Helicobacter pylori. Two randomized pilot studies

et al. 2019

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Background Bismuth is no longer available in Europe except as part of combination therapy. Lactobacillus reuteri has also been used as an adjuvant for Helicobacter pylori therapy. We aimed to investigate the efficacy of a b.i.d. quadruple therapy containing Pylera® or L reuteri for H pylori infection. Materials and Methods We performed two open‐label randomized pilot studies. Adult patients positive for H pylori were randomly assigned to b.i.d therapy with quadruple therapy containing bismuth (2 capsules of Pylera® plus 250 mg each of tetracycline and metronidazole for a total of 500 mg of each), or the same dose of antibiotics plus 2 × 108 CFU L reuteri DSM 17 938 plus 2 × 108 CFU L reuteri ATCC PTA 6475 (Gastrus®) once daily and pantoprazole 20 mg b.i.d. Regimens were given with meals for 10 days. Cure was defined by negative 13C‐UBT or stool antigen test. Results A total of 99 subjects (29% men) were enrolled; 92 completed the study. In the Pylera® group, H pylori infection was cured in 95.7%; 95% CI = 85%‐99% (44/46) PP and 88%; 95% CI = 75%‐95% (44/50) ITT vs. 84.8%; 95% CI = 71%‐95% (39/46) PP and 79.6%; 95% CI = 65%‐89% (39/49) ITT in the Gastrus® group, respectively. Cure rates in naїve patients were 100%; 95% CI = 85%‐100% (25/25) PP with Pylera®, and 89.7%; 95% CI = 72%‐97% (26/29) with Gastrus®. Compliance was excellent and side effects mild with both regimens. Conclusions B.i.d. bismuth quadruple therapy was highly effective for H pylori eradication in treatment of naïve patients in Sardinia. Replacement of bismuth with Gastrus® might be considered when bismuth is contraindicated or unavailable.

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“…This was a prospective single‐center, randomized, open‐label trial conducted as two pilot studies in adult patients with H pylori infection as described previously …”

Section: Methodsmentioning

confidence: 99%

Twice‐a‐day PPI, tetracycline, metronidazole quadruple therapy with Pylera® or Lactobacillus reuteri for treatment naïve or for retreatment of Helicobacter pylori. Two randomized pilot studies

et al. 2019

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“…Recently, two pilot non-randomized studies evaluated 10 day twice a day rifabutin triple therapy and separately a 10 day rifabutin quadruple therapy in which bismuth subcitrate was added twice a day. In this quadruple therapy, the cure rate without the addition of bismuth was poor (66.7%) but increased to 96.6% (28/29) with the addition of bismuth [56]. At this time one can only conclude that the details for producing a reliable rifabutin-containing therapy are still unknown.…”

Section: Rifabutin-containing Regimensmentioning

confidence: 99%

Helicobacter pyloritherapy: a paradigm shift

Graham

Dore

2016

Expert Review of Anti-infective Therapy

108

124

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SUMMARY Helicobacter pylori (H. Pylori) is a leading cause of gastroduodenal disease, including gastric cancer. H. pylori eradication therapies and their efficacy are summarized. A number of current treatment regimens will reliably yield >90% or 95% cure rates with susceptible strains. None has proven to be superior. We show how to predict the efficacy of a regimen in any population provided one knows the prevalence of antibiotic resistance. As with other infectious diseases, therapy should always be susceptibility-based. Susceptibility testing should be demanded. We provide recommendations for empiric therapies when the only option and describe how to distinguish studies providing misinformation from those providing reliable and interpretable data. When treated as an infectious disease, high H. pylori cure rates are relatively simple to reliably achieve.

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“…A study from Japan found in third‐ or fourth‐line therapy that 83.3% achieved eradication after 10 days of rifabutin‐based triple therapy and 94.1% after 14 days . A separate pilot study from Italy reported 96.6% for a 10‐day bismuth‐based quadruple regimen containing rifabutin compared to 66.7 in the 10‐day rifabutin‐based triple therapy arm . Less impressive results were found in a 12‐patient cohort in Korea in whom only 50% achieved eradication although this study was significantly skewed by the fact that some patients received therapy for 7 days and others 14 days .…”

Section: Rifabutinmentioning

confidence: 70%

Treatment of Helicobacter pylori infection 2017

et al. 2017

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Over the last decade, it has been widely reported that the success of Helicobacter pylori eradication treatment is falling. A steady decline was observed in the number of patients achieving eradication with standard first-line triple therapy of two antibiotics and a proton pump inhibitor [1][2][3]. It now appears that the first-line eradication therapies most commonly used in everyday clinical practice fall considerably short of the 80% intention-to-treat (ITT) eradication rates that are considered the minimal acceptable levels as recommended in the Maastricht guidelines [4]. Interestingly, two studies emerged from Asian centers in the last 12 months, which show that, in this part of the world at least, eradication levels using standard therapies remain close to 80%. A Malaysian study showed a standard 1-week pantoprazole, amoxycillin, and clarithromycin regimen to be well tolerated and highly efficacious with a per-protocol eradication rate of 84% [5]. A Japanese study showed remarkably consistent per-protocol eradication rates from 2001 to 2009 fluctuating between 75 and 78% for standard 7-day triple-therapy regimens [6]. A limit of many studies especially those including clarithromycin or levofloxacin is that H. pylori susceptibility to the drugs, which is the main prediction of failure, was not tested. LevofloxacinThe use of levofloxacin as a first-line therapy has been examined in great depth in the last year. Levofloxacin may be used as a substitute for clarithromycin in either a standard triple or sequential regimen. A large study comparing the antibiotics in either regimen shows a clear advantage to levofloxacin in both combinations. Per-protocol cure rates for triple therapy were 66% for omeprazole-clarithromycin-amoxycillin compared with 83% for omeprazole-levofloxacin-amoxycillin and 81% for omeprazole-amoxycillin-clarithromycin-metronidazole vs 85% for omeprazole-amoxycillin-levofloxacinmetronidazole, with no difference in compliance rates or adverse events [7]. It has been proposed that sequential levofloxacin-based regimens are of most benefit in areas where clarithromycin resistance is in excess of 15%, and another study in such an area showed eradication rates of 81% with clarithromycin sequential therapy compared with 96% with levofloxacin sequential therapy. A third arm in this study looked at the dose of levofloxacin required and illustrated no benefit in increasing the dose from 250 to 500 mg [8]. Indeed, another study went so far as to suggest that once-daily dosing of a levofloxacin-based triple regimen may be as efficacious as twice daily [9]. The literature from Asia also seems to support levofloxacin as a good alternative first-line therapy. A study on a triple regimen showed per-protocol eradication rates of 78% for standard clarithromycin-containing therapies compared with 83% for a levofloxacin-based regimen [10]. Another study from the Middle East looked at whether combining clarithromycin and levofloxacin in the same regimen could be Keywords Peptic ulcer disease, resistance, compli...

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Rifabutin Containing Triple Therapy and Rifabutin with Bismuth Containing Quadruple Therapy for Third‐Line Treatment of Helicobacter pylori Infection: Two Pilot Studies

Abstract: The addition of bismuth subcitrate to a triple therapy that includes proton pump inhibitors, amoxicillin, and rifabutin in patients who are treated for the third time for H. pylori infection resulted in a 30% therapeutic gain.

Cited by 32 publications

References 53 publications

Twice‐a‐day PPI, tetracycline, metronidazole quadruple therapy with Pylera® or Lactobacillus reuteri for treatment naïve or for retreatment of Helicobacter pylori. Two randomized pilot studies

Twice‐a‐day PPI, tetracycline, metronidazole quadruple therapy with Pylera® or Lactobacillus reuteri for treatment naïve or for retreatment of Helicobacter pylori. Two randomized pilot studies

Helicobacter pyloritherapy: a paradigm shift

Treatment of Helicobacter pylori infection 2017

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